Image Essentials One Step Pregnancy Test

GUDID 00883967296927

FPPL Kmart Image Essentials DPS +/-

KMART HOLDING CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00883967296927
NIH Device Record Key944a05cb-acd0-4e10-830e-a0b881efcd2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage Essentials One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS131978533
Company NameKMART HOLDING CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx
Phone800-842-7886
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100633472000133 [Unit of Use]
GS100883967296927 [Primary]
GS110883967296924 [Package]
Package: Shipping Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-04

On-Brand Devices [Image Essentials One Step Pregnancy Test]

00883967296927FPPL Kmart Image Essentials DPS +/-
00883967296910FPPL Kmart Image Essentials SPS +/-

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.